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Organization name
UDI-DI code
Reference / catalog number

Gelmax® Tampon, x 25 — Class I MDR by CLEANIS

MD Atlas
CLEANIS

EUDAMED last updated this device on Aug 27, 2025

Gelmax® Tampon, x 25

376005923RECUEILEXCDT03B4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CLEANIS
UDI-DI code: 03760059230212
Reference / catalog number: 9582104

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Manufacturer information

Organization name: CLEANIS
SRN: FR-MF-000004677
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
Usage unique, en cas de réutilisation risque d’absorption insuffisante voire nulle et donc de contamination potentielle et d’inconfort pour le patient. Ne pas mettre en contact de peau lésée. Ne pas utiliser ce produit pour gélifier les produits chimiques suivants : acides forts (concentrations>3%), bases fortes (concentrations>10%) et agents oxydants forts. Ne pas laisser à la portée des enfants. En cas de contact du tampon avec l'œil ou les muqueuses, rincer abondamment à l'eau. En cas de gêne persistante, contacter votre médecin. En cas d'ingestion consulter immédiatement un médecin et lui montrer l'emballage.

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: Gelmax® Tampon, x 25
UDI-DI code: 03760059230212
Basic UDI-DI: 376005923RECUEILEXCDT03B4
Reference / catalog number: 9582104
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 25
Additional product description: Tampon super- absorbant (capacité d'absorption de 450ml de solution saline0,9%, équivalent fluides biologiques) destiné à la gélification des fluides corporels dans un bac de collecte, un container à déchets ou dans divers contenants de type bassine. Il peut aussi être utilisé pour augmenter la capacité d’absorption des sacs CareBag® si nécessaire
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0880MEDICAL SUPPORT EQUIPMENT - ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.